SAFE Early Intervention for At-Risk Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SAFE Early Intervention Program, NDT TREATMENT.
- Who it may be relevant to
- Registry conditions: High Risk Infant, Neurodevelopmental Disorder (Diagnosis), Preterm. Basic parameters: 3 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of the Effectiveness of the SAFE Early Intervention Approach on Upper Extremity Function, Fine Motor Skills, and Quality of Life in High-Risk Infants
Overview
This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group. Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities. Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills. Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.
Detailed description
This randomized controlled study investigates the effects of two different early intervention approaches in high-risk infants. The SAFE intervention program is compared with conventional Neurodevelopmental Treatment (NDT). Assessments include upper extremity function, fine motor development, and developmental outcomes measured at baseline and follow-up periods. The study aims to determine which intervention provides superior improvement in early motor and developmental skills.
Interventions
- Behavioral SAFE Early Intervention Program
Structured early intervention program designed for high-risk infants focusing on upper extremity function, fine motor development, and neurodevelopmental outcomes during 8 weeks, 5 days/week - Behavioral NDT TREATMENT
Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week
Primary outcome measures
- Hand Assessment for Infants (HAI) [Time frame: Baseline and after 8 weeks of intervention]
- Peabody Developmental Motor Scales - Second Edition (PDMS-2) [Time frame: Baseline and after 8 weeks of intervention]
Secondary outcome measures (2)
- Canadian Occupational Performance Measure (COPM) [Time frame: Baseline and after 8 weeks of intervention]
- PedsQL™ Infant Quality of Life Scale (1-12 Months) [Time frame: Baseline and after 8 weeks of intervention]
Eligibility criteria
Inclusion criteria
- Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent
Exclusion criteria
- Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Gazi University Faculty of Health Sciences — Ankara
Identifiers
NCT: NCT07596147 · 2026 - 86 · THESIS